Home > Pharmacy > Analytical chemistry > Volume-6 > Issue-6 > Method Development, Validation and Forced Degradation Studies of Dapagliflozin and Pioglitazone Hydrochlorides in Synthetic Mixtures by RP-HPLC

Method Development, Validation and Forced Degradation Studies of Dapagliflozin and Pioglitazone Hydrochlorides in Synthetic Mixtures by RP-HPLC

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Method Development, Validation and Forced Degradation Studies of Dapagliflozin and Pioglitazone Hydrochlorides in Synthetic Mixtures by RP-HPLC


Mr. Tarang Patel | Ronak Parikh



Mr. Tarang Patel | Ronak Parikh "Method Development, Validation and Forced Degradation Studies of Dapagliflozin and Pioglitazone Hydrochlorides in Synthetic Mixtures by RP-HPLC" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-6, October 2022, pp.1858-1869, URL: https://www.ijtsrd.com/papers/ijtsrd52165.pdf

A simple, sensitive, robust, precise, and efficient RP-HPLC approach for the simultaneous determination of Dapagliflozin and Pioglitazone Hydrochloride in Synthetic Mixture. As per ICH Q2 (R1) guidelines, the final chromatographic conditions were Optimized with a mobile phase ratio of (25:75% v/v) in ACN: Potassium Dihydrogen Phosphate Buffer (pH 4) was adjusted by adding OPA at a flow rate of 1 mL/min, column temperature of 30 °C, injection volume of 20 µL, Kromstar Vertex C18 analytical column, and UV detection at 228 nm wavelength. Dapagliflozin and Pioglitazone Hydrochloride reported retention times of 3 min and 6.5 min, respectively. Validation of a method was found to be linear in the range of 2-10 µg/ml for Dapagliflozin and 3–15 µg/mL for Pioglitazone Hydrochloride. The % Recovery for Dapagliflozin was discovered to be 98.52 - 99.90 %, while for Pioglitazone Hydrochloride, it was found to be 99.67- 99.94 %. The Precision results for both drugs were within the limits while expressed Intraday and Interday. For Dapagliflozin, the LOD and LOQ were reported to be 0.041 µg/mL and 0.13 µg/mL, respectively, and for Pioglitazone Hydrochloride, 0.105 µg/mL and 0.32 µg/mL. As per ICH Q1A (R2) guidelines, the synthetic mixture was subjected to acid, base, oxidation, thermal, and photolysis stress conditions.

RP-HPLC, Dapagliflozin, Pioglitazone Hydrochloride, Forced Degradation, ICH guidelines


IJTSRD52165
Volume-6 | Issue-6, October 2022
1858-1869
IJTSRD | www.ijtsrd.com | E-ISSN 2456-6470
Copyright © 2019 by author(s) and International Journal of Trend in Scientific Research and Development Journal. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (http://creativecommons.org/licenses/by/4.0)

International Journal of Trend in Scientific Research and Development - IJTSRD having online ISSN 2456-6470. IJTSRD is a leading Open Access, Peer-Reviewed International Journal which provides rapid publication of your research articles and aims to promote the theory and practice along with knowledge sharing between researchers, developers, engineers, students, and practitioners working in and around the world in many areas like Sciences, Technology, Innovation, Engineering, Agriculture, Management and many more and it is recommended by all Universities, review articles and short communications in all subjects. IJTSRD running an International Journal who are proving quality publication of peer reviewed and refereed international journals from diverse fields that emphasizes new research, development and their applications. IJTSRD provides an online access to exchange your research work, technical notes & surveying results among professionals throughout the world in e-journals. IJTSRD is a fastest growing and dynamic professional organization. The aim of this organization is to provide access not only to world class research resources, but through its professionals aim to bring in a significant transformation in the real of open access journals and online publishing.

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